RIVOTRIL 0.5 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLONAZEPAM, MAGNESIUM STEARATE PH.EUR.

Available from:

Roche Products Limited

ATC code:

N03AE01

INN (International Name):

CLONAZEPAM, MAGNESIUM STEARATE PH.EUR.

Dosage:

0.5 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Benzodiazepine derivatives

Authorization status:

Authorised

Authorization date:

1977-04-01

Patient Information leaflet

1
ie-spc-rivotril-pil-clean-170811-0.5-2.0-tabs
IRELAND
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIVOTRIL
® 0.5 MG AND 2 MG TABLETS
Clonazepam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Rivotril is and what it is used for
2. What you need to know before you take Rivotril
3. How to take Rivotril
4. Possible side effects
5. How to store Rivotril
6. Contents of the pack and other information
1.
WHAT RIVOTRIL IS AND WHAT IT IS USED FOR
Rivotril contains the active substance clonazepam, which belongs to a
group of medicines called
benzodiazepines.
Rivotril is used to treat epilepsy in infants, children and adults.

It lowers the number of fits (seizures) that you have.

Any fits that you do have will be less serious.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIVOTRIL
DO NOT TAKE RIVOTRIL IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO:

Clonazepam or any of the other ingredients of Rivotril (listed in
Section 6).

Other benzodiazepine medicines, such as diazepam, flurazepam and
temazepam.
Do not take Rivotril if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist
before taking Rivotril.
DO NOT TAKE RIVOTRIL IF YOU HAVE:

breathing problems or lung disease.

severe liver problems.

a condition called ‘sleep apnoea syndrome’ (where your breathing
stops when you are asleep).

problems with alcohol or drug (prescription or recreational) use.
Do not take Rivotril if any of the above apply to you. If you are not
sure, talk to your docto

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivotril
0.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 micrograms (0.5 mg) clonazepam.
Excipients: Also contains 40mg lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Round dull pinkish-buff tablets with ‘ROCHE 0,5’ imprinted on one
face and a single break mark on the other.
The tablets can be broken into equal halves to facilitate dosing.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rivotril is indicated, primarily as an adjunct or in refractory cases,
in most forms of epilepsy especially absence
seizures including atypical absence seizures; Lennox-Gastaut syndrome;
myoclonic and atonic seizures. For infantile
spasms (including West-Syndrome) and tonic-clonic seizures it is only
indicated as an adjunct or in refractory cases.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The scored 0.5 mg tablets facilitate the administration of lower daily
doses in the initial stages of treatment.
To break the tablet, hold it with the score facing up and apply
downward pressure.
Posology
_ADULTS_
Initial dosage should not exceed 1 mg/day. The maintenance dosage for
adults normally falls within the range 4 to 8
mg.
_ELDERLY_
The elderly are particularly sensitive to the effects of centrally
depressant drugs and may experience confusion. The
lowest possible dose should be used in the elderly. It is recommended
that the initial dosage of Rivotril should not
exceed 0.5 mg/day and particular care should be taken during
uptitration.
These are total daily dosages which should be divided into 3 or 4
doses taken at intervals throughout the day. If
necessary, larger doses may be given at the discretion of the
physician, up to a maximum of 20 mg daily. The
maintenance dose should be attained after 2 to 4 weeks of treatment.
_INFANTS AND CHILDREN_
To ensure optimum dosage adjustment, children should be given the 0.5
mg tablets.
Initial dosage should not exceed 0.25mg/day for infants